INFX-8000V Interventional Angiography System. CAT-880B catheterization table. Cardiac and Vascular intervention with fluoroscopic and fluorographic images. For the USA and Canada the system is registered as lnfinix CF-i or lnfinix VF-i, for national regulations. INFX-8000V series includes a floor mounted multi-axis positioner.
FDA Recall Z-1394-2015 · Posted 2015-04-06
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Recalling FirmToshiba American Medical Systems Inc
Recall StatusTerminated
Product CodeOWB
Date Initiated2015-03-11
Date Terminated2015-09-18
Product Quantity28 units
Reason for Recall
The table base rotational brake that holds the table top may not always be engaged when any force or side impact is applied to the table top.
Firm Action
Toshiba sent a Urgent Medical Device Correction letter dated March 11, 2015, to all customers who purchased the CAT-880B catherization table for the Tosiba Infinix X-Ray Interventional System. The letter informed the customers of the problems identified and the actions to be taken. Customers were instructed to complete and return the attached form and fax it to (877) 349-3054 or email to [email protected]. Customers with questions were instructed to call (800) 421-1968 or contact their local Toshiba Representative at (800) 521-1968.
For questions regarding this recall call 714-730-5000.
Root Cause
Device Design
Distribution Pattern
Nationwide Distribution
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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